# FDA 483 - Pharmco Laboratories Inc. - September 22, 2021

Source: https://www.globalkeysolutions.net/records/483/pharmco-laboratories-inc/8047a27a-811d-40be-8578-1acbe1e7ba66

> FDA 483 for Pharmco Laboratories Inc. on September 22, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmco Laboratories Inc.
- Inspection Date: 2021-09-22
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Pharmco Laboratories Inc. in Titusville, FL, was inspected and received a Form 483 with 10 observations, indicating significant deficiencies in their drug manufacturing operations. The inspection revealed widespread issues including inadequate equipment cleaning and maintenance, poor facility upkeep, insufficient process and water system validations, and failures in quality control. Additionally, problems were identified with laboratory controls and the proper management of drug product reserve samples.

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## Related Officers

- [Investigator ](https://www.globalkeysolutions.net/people/nicole-e-knowlton/8e65400f-249f-45fe-96fc-cb00fec6ae39)

Company: https://www.globalkeysolutions.net/companies/pharmco-laboratories-inc/b34e3481-0ea5-433a-9e03-ce66b44df443

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6